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SPRING 2013 T h e Spirog ram ! Pulmonary Hypertension Sanjiva Lutchmedial , M.D. Pulmonary hypertension is a rare CONTRIBUTORS SANJIVA LUTCHMEDIAL, MD DAVID KAMINSKY, MD DAVID CHAPMAN, PHD RESEARCH COORDINATORS STEPHANIE BURNS SANDRA DIEHL JOAN LIPPMANN PATTI LUTTON MEENA SUBRAMANIAN INSIDE THIS ISSUE: Pulmonary Hypertension 1 World Lung Health Day 2 Ongoing Studies 3 New Asthma Study 4 lung disorder in which the arteries that carry blood from the heart to the lungs become narrow, making it dif9icult for blood to 9low through the vessels. As a result the pressure in these arteries rise far above normal levels which strains the right ventricle of the heart causing it to lose its ability to pump blood through the lung. This results in right heart failure. Symptoms of pulmonary hypertension usually do not occur until the condition has progressed substantially. The 9irst symptom is usually shortness of breath with everyday activity, such as climbing stairs. Chest pain and fainting spells may also occur. Because pulmonary hypertension may be caused by many medical conditions, a complete history and physical examination are necessary to rule out other diseases. Further tests may include blood tests, an echocardiogram and lung function test, which are needed to con9irm the diagnosis. Treatment varies per individual based on the different underlying causes, but generally includes taking medications, making lifestyle changes and surgery if necessary. Where in the past doctors had very little to offer in terms of treatment options, this has changed dramatically in recent years. Currently at the Vermont Lung Center we are conducting a clinical research study to help us understand more about the changes in the lung that occur with pulmonary hypertension. We are interested in determining whether a simple lung function test, the DLCO, can be used to follow and monitor patients with pulmonary hypertension undergoing treatment. The Vermont Lung Center participated in the May 1 rally held on the lawn of the Capital Building in Montpelier sponsored by the Vermont Workers Center. The VLC was there to offer pulmonary function testing as part of free community health screenings WWW.VERMONTLUNG.ORG SPRING 2013 World Lung Health Day: Changing the Tide of Lung Disease During World Lung Health Day on June 12, 2013, the Vermont Lung Center will join Institutes around the world in offering free lung function testing. So why should you have your lung function tested? The main role of the lung is to transport oxygen from the environment into the blood stream and transport carbon dioxide from the blood back out. It’s not surprising that how effective the lung functions in transporting air becomes a major indication of the presence of disease. However, lung function testing is often underutilized and therefore lung disease remains vastly under recognized. It is not uncommon to find that spirometry uncovers nearly 20% of people with some degree of lung abnormality, which is usually related to chronic obstructive lung disease or asthma. Although chronic obstructive lung disease is largely preventable, it remains the 3rd leading cause of death in the US, in large part due to under diagnosis of the disease. We hope to begin to reverse this trend by offering free lung function testing during World Lung Health Day. Both chronic obstructive lung disease and asthma can lead to narrow airways which reduce the speed at which you can blow air out of your lungs. We can measure this by simple blowing out tests, known as spirometry. The most common spirometry test measures the amount of air you can blow out in one second, called the “Forced Expiratory Volume in one second” or FEV1. Although FEV1 differs widely between people, once we take into account your height, age and sex, we can tell how well your lung functions compared to if you had “healthy” lungs. Although chronic obstructive lung disease is predominantly due to the effects of tobacco smoke a less common cause is related to genetics. In most people, the enzyme alpha-1 antitrysin protects the lung from damage; however, some people have a deficiency in alpha-1 antitrysin which leads to lung disease similar to that caused by smoking. It is estimated that up to 3% of patients with COPD may have undetected AAT deficiency. The World Health Organization, American Thoracic Society and European Respiratory Society recommend that all patients with chronic obstructive lung disease be tested for AAT deficiency. This can be done by a simple fingerstick blood test. As part of World Lung Health Day, the Vermont Lung Center, with the support of the Alpha 1 Foundation, will also be offering free blood testing for AAT deficiency. Look for us at the Davis Center Concourse from 10:00-2:00 on June 12th. The tests are simple and the experts are waiting, so why not join the Vermont Lung Center for World Lung Health Day! David Chapman, PhD David Kaminsky, MD INTERESTED IN VOLUNTEERING? Things to know.: 1) The Vermont Lung Center staff is responsible for making sure you know what is expected of you in regards to the study. 2) Once the study is explained to you, you will be asked to read and sign an“Informed Consent”. This form is designed to explain everything you need to know about the study. 3) Studies may be therapeutic (involving observation of lung function). However The Vermont Lung Center can make no claims that your involvement in a research study will improve your condition. 4) Compensation may or may not be provided to you for your involvement in a study. If compensation is provided, it is meant to cover your time and expenses incurred-it does not constitute employment. If you are interested in finding out more about volunteering for a research study, please call us at (802) 847-2193 WWW.VERMONTLUNG.ORG ONGOING STUDIES AT THE VERMONT LUNG CENTER ASTHMA Asthma Patient Registry (APR) Primary Investigator: Charles Irvin, Ph.D., Director, VLC Coordinator: Kathleen Dwinell Who: Anyone with a physician diagnosis of asthma What: 1 visit lasting approximately 30 minutes Compensation: none LASST (Long-acting Beta Agonist Step Down Study Primary Investigator: Charles Irvin, Ph.D., Director, VLC Coordinator: Stephanie Burns Who: Asthmatics ages 12 and older What: 11 visits Compensation: $75 per visit SAPS (Smoking Asthmatics Cohort Study) Primary Investigator: Charles Irvin, Ph.D., Director, VLC Coordinator: Stephanie Burns Who: Asthmatics ages 18 to 50 who smoke What: 2 visits Compensation: up to $175 CPAP (Effect of Positive Airway Pressure on Airway Reactivity in Patients with Asthma) Primary Investigator: Charles Irvin, Ph.D., Director, VLC Coordinator: Stephanie Burns Who: Asthmatics ages 15-60 What: 6 visits Compensation: up to $600 Epithelial Duox1, IL-33, and Allergic Inflammation Primary Investigator: Anne Dixon, M.D. Coordinator: Joan Lippmann Who: Asthmatics and Non-Asthmatics ages 18 and older What: 1 visit Compensation: $25 Assessing the Effects of Lung Volume and Time on Airway Responsiveness in Asthmatic Subjects Primary Investigator: Jason Bates, Ph.D. Coordinator: Stephanie Burns Who: Asthmatics and Non-Asthmatics ages 18 and older What: 3 visits Compensation: $25 per visit ACIA: Non-invasive Detention of Airway Injury Associated with Airway Closure in Asthmatic Subjects Primary Investigator: David Kaminsky, M.D. Coordinator: Meena Subramanian Who: Moderate to Severe Asthmatics ages 18 and older What: 5 visits Compensation: up to $100 Study of Changes in Allergic Inflammation and Airway Remodeling During Bariatric Surgery Primary Investigator: Anne Dixon, M.D. Coordinator: Stephanie Burns Who: Asthmatics ages 18 and older having bariatric surgery What: 2 visits Compensation: $25 per visit Effects of Obesity on Allergic Airway Inflammation Primary Investigator: Anne Dixon, M.D. Coordinator: Meena Subramanian Who: Asthmatics ages 18 or older allergic to dust mites What: 2 visits Compensation: up to $200 SPRING 2013 IDIOPATHIC PULMONARY FIBROSIS (IPF) Primary Investigator: Yolanda Mageto, M.D. Coordinator: Patricia Lutton Coming this summer CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Forest: A 52-week, Double-Blind, Randomized, PlaceboControlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS) Primary Investigator: Anne Dixon, M.D. Coordinator: Meena Subramanian Who: People with COPD and Chronic Bronchitis What: 8 visits over 1 year Compensation: $50 per visit. Advair 250/50 or Symbicort 160/4.5 and Albuterol provided. Study of the Effects of Education on Patients with COPD Primary Investigator: David Kaminsky, M.D. Coordinator: Joan Lippmann Who: People with COPD What: 7 visits over 12 weeks Voucher-based incentives to promote smoking abstinence among patients with chronic obstructive pulmonary disease Primary Investigator: Stacey Sigmon, Ph.D. Co-Investigators: Anne Dixon, M.D., Charlotte Teneback, M.D. Coordinator: Mollie Patrick Who: Smokers who are over age 35 and have a diagnosis of COPD What: 2-wk study with brief daily visits for monitoring smoking status Compensation: Up to $587.50 CYSTIC FIBROSIS A Phase 2, Multicenter, DoubleBlinded, PlaceboControlled, 3-Part Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX661 Monotherapy and VX661/VX770 Cotherapy in Subjects with Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Primary Investigators: Laurie Leclair MD /Thomas Lahiri MD Coordinators: Joan Lippmann/Sandra Diehl Who: People with Cystic Fibrosis What: 9 visits over 2.5 month period including 28 days treatment Compensation: Up to $1150 A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis Primary Investigator: Laurie Leclair, M.D. Coordinator: Sandra Diehl Who: People with Cystic Fibrosis What: 9 visits over 8.5 month period including 6 months treatment Compensation: Up to $675 A phase 2, Randomized Double-blind, Placebo-controlled, Repeat-dose study of KB001-A in Subjects with Cystic Fibrosis Infected with Pseudomonas aeruginosa Primary Investigator: Laurie Leclair, M.D. Coordinator: Joan Lippmann Who: People with Cystic Fibrosis What: 9 visits over 8.5 month period including 6 months treatment Compensation: Up to $675 WWW.VERMONTLUNG.ORG The Vermont Lung Center The University of Vermont Medical Of;ice Bldg., Suite 305 792 College Parkway Colchester VT 05446 Non-‐Profit Org. U.S. Postage PAID Permit No. 143 Burlington, VT SPRING 2013 The Vermont Lung Center is affiliated with the following organizations: The Vermont Lung Center is supported in part by the following organizations: Smokers with asthma needed… You may be eligible to participate in a research study Are you between the ages of 18 to 50? Do you have physician-diagnosed asthma? Do you smoke at least five cigarettes per day? Participants will be compensated Call the Vermont Lung Center 847-8839